FDA UDI
In Commercial Distribution
🇺🇸 United States
NightGuard Flex
DI: 00850039704062
·
Model: SRI-0202015
·
Sprintray, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NightGuard Flex
- Primary DI
- 00850039704062
- Version / Model
- SRI-0202015
- Catalog Number
- SRI-0202015
- Company Name
- Sprintray, Inc.
- Labeler DUNS
- 063005260
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-28
- Public Version
- 2
- Public Version Date
- 2024-02-29
- Public Version Status
- Update
- Public Device Record Key
- 687dbe7a-e4fb-4e63-93ad-c33349b0dd2a
Device Description
Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. 3D scanned image of a patient's teeh
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KMY | Positioner, Tooth, Preformed | Dental | 872.5525 | 1 |
| MQC | Mouthguard, Prescription | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16730 | Dental appliance fabrication material, resin | A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850039704069 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 00850039704062 | GS1 |
Customer Contacts
- Phone
- 800-914-8004
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212448 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 1 | Liter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material.